CGMP Deviations
All Recalls
95,025 total recalls in our database
Microbial Contamination of Non-Sterile Products; lot tested positive for Bulkholderia multivorans
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
CGMP Deviations
Itraconazole Capsules, 100 mg, 30-count bottles, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-282-30.
Jubilant Cadista Pharmaceuticals
Failed Dissolution Specifications
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
Roche Molecular Systems
Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate layer in the package may also impact complete de-gassing of the sterilization gas, Ethylene Oxide and may result in a potentially increased risk for patient infection and/or potential exposure to Ethylene Oxide retained in the pouch
SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
Sunstar Americas
Product may be contaminated with Burkholderia contaminans.
The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190
Roche Molecular Systems
Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on the cobas Liat analyzer, showed abnormal PCR growth curves
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the empty single-use reload is fired a second time, the stapler may cut tissue but no staples will deploy from the empty reload, potentially resulting in a failed anastomosis, bleeding, tissue trauma, and the potential need to convert to an open procedure.
ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Siemens Healthcare Diagnostics
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Possible false negative or false positive results due to the product being compromised during shipment.